Safety and Pharmacokinetics of Recombinant Factor XIII in Healthy Volunteers

Phase 1 Completed 50 enrolled Novo Nordisk A/S

RandomizedParallel-groupDouble-blindTreatment

Summary

This trial was conducted in Europe. The aim of this trial was to investigate safety and pharmacokinetics of escalating single doses of catridecacog (recombinant factor XIII, rFXIII) in healthy volunteers.

Timeline

Start: 2003-01
Primary completion: 2003-05
Completion: 2003-05

Publications

Results Visich JE, Zuckerman LA, Butine MD, Gunewardena KA, Wild R, Morton KM, Reynolds TC. Safety and pharmacokinetics of recombinant factor XIII in healthy volunteers: a randomized, placebo-controlled, double-blind, multi-dose study. Thromb Haemost. 2005 Oct;94(4):802-7. doi: 10.1160/TH05-04-0292.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	catridecacog	Protein / enzyme biologic	2 iu/kg	Intravenous
Subject	catridecacog	Protein / enzyme biologic	5 iu/kg	Intravenous
Subject	catridecacog	Protein / enzyme biologic	10 iu/kg	Intravenous
Subject	catridecacog	Protein / enzyme biologic	25 iu/kg	Intravenous
Subject	catridecacog	Protein / enzyme biologic	50 iu/kg	Intravenous

Safety and Pharmacokinetics of Recombinant Factor XIII in Healthy Volunteers

Summary

Timeline

Publications

Drugs

Indications